Jaw, EdentulousdentureNCT00959530
Comparison of Lingualized and Full Bilaterally Balanced Articulation
A study testing lingualized occlusion and Full Bilaterally Balanced Articulation in people with Jaw, Edentulous, run by Nihon University at 1 site in Japan.
Trial summary
The purpose of this study is to find the difference between patient satisfaction, masticatory performance and cost between two occlusal schemes for complete denture prosthodontics. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Jaw, Edentulous
- What is being tested?
- lingualized occlusion and Full Bilaterally Balanced Articulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2007to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- edentulous both maxilla and mandible, asking for new denture fabrication
Who cannot join
- psychiatric problem
- those who have difficulty answering the questionnaire
- oral cancer
- radiation experience
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Trial Comparing Lingualized and Full Bilaterally Balanced Articulation for Complete Dentures
The purpose of this study is to find the difference between patient satisfaction, masticatory performance and cost between two occlusal schemes for complete denture prosthodontics.
Read the detailed description
Two occlusal scheme applied to complete denture prosthodontics has been compared in RCT. This will have clinical benefit for deciding which occlusal scheme is better according to patient conditions. It will also have impact on dental educational curriculum.
- Conditions
- Jaw, Edentulous
- Being tested
- lingualized occlusion, Full Bilaterally Balanced Articulation
- Keywords
- complete dentures, patient satisfaction, treatment cost
- Medical subject headings
- Jaw, Edentulous, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lingualized occlusionProcedure or surgery
Also called e-ha artificial teeth, shofu porcelain teeth
occlusal surface arranged by lingualized occlusion
Full Bilaterally Balanced ArticulationProcedure or surgery
Also called Shofu Ace Posterior
occlusal surface arranged by Full Bilaterally Balanced Articulation
| Study group | Role | What they receive |
|---|---|---|
| lingualized | Experimental | complete denture fabricated by lingualized occlusion scheme Receives: Procedure: lingualized occlusion |
| Full Bilaterally Balanced Articulation | Placebo comparator | complete denture fabricated by Full Bilaterally Balanced Articulation scheme Receives: Procedure: Full Bilaterally Balanced Articulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction on 100mm visual analogue scale
Measured: 6month
Secondary outcomes (1)
treatment cost
Measured: 6month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2009 (estimated)
- Study startNov 2007
- Primary completionSep 2009
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Jaw, EdentulousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nihon University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasuhiko Kawai, Nihon University
- Investigators
- Yasuhiko Kawai, DDS MMedSc, Principal investigator, Nihon UniversityYuichi Matsumaru, DDS, Principal investigator, Nihon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959530
- Sponsor's protocol ID
- 07-014
- Acronym
- denture
- Status last verified
- Mar 2017
- First submitted
- 13 Aug 2009
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Heydecke G, Vogeler M, Wolkewitz M, Turp JC, Strub JR. Simplified versus comprehensive fabrication of complete dentures: patient ratings of denture satisfaction from a randomized crossover trial. Quintessence Int. 2008 Feb;39(2):107-16.
PubMed 18560649Sutton AF, Worthington HV, McCord JF. RCT comparing posterior occlusal forms for complete dentures. J Dent Res. 2007 Jul;86(7):651-5. doi: 10.1177/154405910708600713.
PubMed 17586713Sutton AF, McCord JF. A randomized clinical trial comparing anatomic, lingualized, and zero-degree posterior occlusal forms for complete dentures. J Prosthet Dent. 2007 May;97(5):292-8. doi: 10.1016/j.prosdent.2007.03.003.
PubMed 17547948Kimoto S, Gunji A, Yamakawa A, Ajiro H, Kanno K, Shinomiya M, Kawai Y, Kawara M, Kobayashi K. Prospective clinical trial comparing lingualized occlusion to bilateral balanced occlusion in complete dentures: a pilot study. Int J Prosthodont. 2006 Jan-Feb;19(1):103-9.
PubMed 16479769Matsumaru Y. Influence of mandibular residual ridge resorption on objective masticatory measures of lingualized and fully bilateral balanced denture articulation. J Prosthodont Res. 2010 Jul;54(3):112-8. doi: 10.1016/j.jpor.2009.11.008. Epub 2010 Jan 19.
PubMed 20089469
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Comparing Lingualized and Full Bilaterally Balanced Articulation for Complete Dentures
- ClinicalTrials.gov ID
- NCT00959530
- Acronym / sponsor ID
- denture / 07-014
- Conditions
- Jaw, Edentulous
- Keywords
- complete dentures, patient satisfaction, treatment cost
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nihon UniversityUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 14 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find the difference between patient satisfaction, masticatory performance and cost between two occlusal schemes for complete denture prosthodontics.
Detailed description
Two occlusal scheme applied to complete denture prosthodontics has been compared in RCT. This will have clinical benefit for deciding which occlusal scheme is better according to patient conditions. It will also have impact on dental educational curriculum.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lingualized | Experimental | Procedure: lingualized occlusioncomplete denture fabricated by lingualized occlusion scheme |
| Full Bilaterally Balanced Articulation | Placebo comparator | Procedure: Full Bilaterally Balanced Articulationcomplete denture fabricated by Full Bilaterally Balanced Articulation scheme |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- edentulous both maxilla and mandible, asking for new denture fabrication
Key exclusion criteria (4 listed)
- psychiatric problem
- those who have difficulty answering the questionnaire
- oral cancer
- radiation experience
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lingualized occlusionAlso: e-ha artificial teeth, shofu porcelain teethocclusal surface arranged by lingualized occlusion | Procedure or surgery | lingualized |
| Full Bilaterally Balanced ArticulationAlso: Shofu Ace Posteriorocclusal surface arranged by Full Bilaterally Balanced Articulation | Procedure or surgery | Full Bilaterally Balanced Articulation |
Primary outcome
patient satisfaction on 100mm visual analogue scale
Time frame: 6month
1 secondary outcome
treatment cost
Time frame: 6month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Background: PubMed 18560649Heydecke G, Vogeler M, Wolkewitz M, Turp JC, Strub JR. Simplified versus comprehensive fabrication of complete dentures: patient ratings of denture satisfaction from a randomized crossover trial. Quintessence Int. 2008 Feb;39(2):107-16.
- Background: PubMed 17586713Sutton AF, Worthington HV, McCord JF. RCT comparing posterior occlusal forms for complete dentures. J Dent Res. 2007 Jul;86(7):651-5. doi: 10.1177/154405910708600713.
- Background: PubMed 17547948Sutton AF, McCord JF. A randomized clinical trial comparing anatomic, lingualized, and zero-degree posterior occlusal forms for complete dentures. J Prosthet Dent. 2007 May;97(5):292-8. doi: 10.1016/j.prosdent.2007.03.003.
- Background: PubMed 16479769Kimoto S, Gunji A, Yamakawa A, Ajiro H, Kanno K, Shinomiya M, Kawai Y, Kawara M, Kobayashi K. Prospective clinical trial comparing lingualized occlusion to bilateral balanced occlusion in complete dentures: a pilot study. Int J Prosthodont. 2006 Jan-Feb;19(1):103-9.
- Derived from this study: PubMed 20089469Matsumaru Y. Influence of mandibular residual ridge resorption on objective masticatory measures of lingualized and fully bilateral balanced denture articulation. J Prosthodont Res. 2010 Jul;54(3):112-8. doi: 10.1016/j.jpor.2009.11.008. Epub 2010 Jan 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasuhiko Kawai, DDS MMedSc principal investigator
Nihon University
Yuichi Matsumaru, DDS principal investigator
Nihon University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lingualized occlusion and Full Bilaterally Balanced Articulation in people with Jaw, Edentulous, run by Nihon University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient satisfaction on 100mm visual analogue scale (time frame: 6month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00959530, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.